An interventional study of Chinese Herbs in Breast Cancer and Musculoskeletal Pain, sponsored by Universiti Tunku Abdul Rahman. Recruiting at 1 site in Malaysia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-31.
Sponsored by Universiti Tunku Abdul Rahman · Not applicable, Interventional, and Treatment
Chinese herbs can alleviates the side effects caused by conventional treatment in breast cancer patients and affects the syndrome element differentiation by altering the specific set of proteomes at specific time point of treatment.
The previous studies have reported that adjuvant Chinese herbs therapy can improve the survival of breast cancer patients by alleviating the side effects of conventional treatments. Protein expression determines the phenotype of a patient that contributes to the onset of side effects in breast cancer patients caused by conventional treatment. Chinese herbs treatment will alleviate the treatment-related side effects by altering the protein expression in the patients. Associating changes in protein levels with the onset of side effects caused by conventional treatments could be used to identify clinically relevant diagnostic biomarkers. In addition, a set of proteome that is being expressed at diseased state will exhibit the phenotype that is also correlated to the TCM syndrome differentiation. Hence, this study aims to determine the proteome profile for the syndrome differentiation of breast cancer patients treated with adjuvant Chinese herbs for musculoskeletal pain. A quasi-experimental study with purposive sampling will be conducted on 30 breast cancer patients recruited from Tung Shin hospital. All participants will be invited to complete a structured questionnaire to collect their demographic information, pain score, syndrome element differentiation, quality of life, stress, body constitution and other relevant information, including cancer type, cancer stage, and cancer treatment. The questionnaires will be self-administered either at the outpatient waiting room or in the ward of the study hospital. Blood of the patients will be collected for determination of protein expression, biochemical markers and cytokines. The study is an in-point analysis where 2 time-points of data collection and analysis will be carried out at baseline, and immediate post Chinese herbs treatment. Informed consent will be obtained before participant enrolment according to a clinical trial protocol. Statistical differences for protein expression, biochemical markers, cytokines and mean pain score before and after Chinese herbs treatment will be compared using the paired-sample t test.
12,543 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's planned enrollment of 30 is below the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
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Exclusion Criteria:
Participants received standardized Chinese Herbs treatment orally twice daily for 1 week.
Dietary Supplement: Chinese Herbs
Chinese Herbs
Feasibility of the study (Adherence)
The feasibility of the adherence will be determined by the number of sachets of Chinese herbs taken.
Time frame: Immediate post 1 week of Chinese Herbs intervention
Feasibility of the study (Dropout rate)
The feasibility will be assessed by dropout rate of the patients.
Time frame: Immediate post 1 week of Chinese Herbs intervention
Change in the pain score
The pain score of breast cancer patients will be assessed by Brief Pain Inventory-Short Form (BPI-SF). BPI-SF is a validated and reliable tool used to assess the severity or intensity of pain on scale ranging from 0 (no pain) to 10 (worst pain imaginable). Higher scores mean a worse outcome.
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Syndrome element differentiation
Syndrome Element Differentiation rating scale will be used to determine the syndrome element differentiation of the patients. Syndrome Element Differentiation rating scale can quantify the syndrome elements of this patient based on the clinical manifestations. The quantitative output weight values of syndrome elements are acquired from clinical input data based on the severity and frequency of each sign and symptom. Based on the quantitative output value, the syndrome elements can then be categorized into four levels of health state or severity: normal (\<70), mild (≥ 70 to \<100), moderate (≥100 to \<150), and severe (≥ 150).
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in quality of life as assessed by WHO-BREF (World Health Organization Quality of Life)
The quality of life will be assessed by the WHO-BREF questionnaire in this study. The WHOQOL-BREF instrument comprises 26 items, measuring the following broad domains: physical health, psychological health, social relationships, and environment, with scores ranging from 0 to 100. The four domain scores denote an individual's perception of the quality of life in each domain. Domain scores are scaled in a positive direction in which higher scores denote a higher quality of life. * the minimum and maximum values: 0, 100 * higher scores mean a better outcome.
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in stress
The Depression Anxiety Stress Scales (DASS) is a self-report instrument designed to measure the negative emotional states of depression, anxiety and stress. A short version, the DASS 21 scale consists of a list of 21 symptoms with 7 item per scale, each of which is to be rated on a four-point scale of how much you had that symptom in the last week from 'never' to 'most of the time'. In this study, stress will be determined by stress domain of DASS-21 which consists of 7 items.
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in body constitution assessed by Constitution in Chinese Medicine Questionnaire (CCMQ)
The body constitution will be determined by Constitution in Chinese Medicine Questionnaire (CCMQ). It has 60 items measuring the 9 body constitution types: gentleness, Qi-deficiency, Yang-deficiency, Yin-deficiency, phlegm-wetness, wetness-heat, blood-stasis, Qi-depression, and special diathesis. * the minimum and maximum values: 0, 100 * higher scores mean a worse outcome.
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in protein expression
The serum proteome will be analyzed by liquid chromatography coupled with tandem mass spectrometry (LC-MS/MS).
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Liver Function Test
The liver function of the patients will be determined by measuring the alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase.
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in CEA (Carcino-Embryonic Antigen)
Change in CEA (Carcino-Embryonic Antigen) will be determined by laboratory examination.
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in CRP (C-Reactive Protein)
Change in CRP (C-Reactive Protein) will be determined by laboratory examination.
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Progesterone
Change in Progesterone will be determined by laboratory examination.
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Estradiol
Change in Estradiol will be determined by laboratory examination.
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Change in Cytokine levels of serum
The cytokines in serum samples of breast cancer patients will be detected by the Quantibody array, multiplexed sandwich enzyme-linked immunosorbent assay (ELISA) based quantitative array platform (Genomax technology) for quantitative measurement of cytokines in human serum. The unit of measurement for the cytokines is the same.
Time frame: Baseline and immediate post 1 week of Chinese Herbs intervention
Plan to share: No
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Universiti Tunku Abdul Rahman